CTRI Number |
CTRI/2023/09/057270 [Registered on: 06/09/2023] Trial Registered Prospectively |
Last Modified On: |
04/09/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
To compare the effect of intravenous clonidine versus dexmedetomidine on blood pressure and heart rate during laparoscopic cholecystectomy |
Scientific Title of Study
|
A randomised controlled trial to compare the effect of intravenous clonidine versus dexmedetomidine on hemodynamic response to pneumoperitoneum during laparoscopic cholecystectomy |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Chiteshwar walia |
Designation |
Associate Professor |
Affiliation |
Sr Guru Ram Das Institute of Medical sciences and Research |
Address |
Department of anaesthesia,
Amritsar PUNJAB 143001 India |
Phone |
9878339933 |
Fax |
|
Email |
chiteshwarwalia@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Gurleen Kaur |
Designation |
Junior Resident |
Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
Address |
Department of Anaesthesia
Amritsar PUNJAB 143001 India |
Phone |
9780417889 |
Fax |
|
Email |
drgurleendhaul@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Harpreet Babrah |
Designation |
Assistant Professor |
Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
Address |
Department of Anaesthesia
Amritsar PUNJAB 143001 India |
Phone |
9023448624 |
Fax |
|
Email |
docharpreet21@gmail.com |
|
Source of Monetary or Material Support
|
Department of anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research |
|
Primary Sponsor
|
Name |
Sri Guru Ram Das Institute of Medical sciences and Research |
Address |
Main Operation Theatre, Department of anaesthesia |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ruchi Gupta |
Sri Guru Ram Das Institute of Medical Sciences and Research |
OT no 2 and 4, Main Operation Theatre,Department of anaesthesia, Amritsar PUNJAB |
9814020805
drruchisgrd@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SGRD Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
General anaesthesia |
premedication of receiving clonidine 0.75 μg/ kg in normal saline or dexmedetomidine 0.75 μg/ kg in normal saline(15 min) |
Comparator Agent |
Normal saline |
receiving 50 ml of normal saline |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
ASA grades I and II
|
|
ExclusionCriteria |
Details |
1. Patients not giving consent
2. Any heart block, preexisting hypertension, cardiovascular disease
3. Hepatic and renal disease
4. Allergies to the drugs used
5. Acute cholecystitis
6. Pregnant ladies and lactating mothers
7. Patients taking clonidine, methyl-dopa, beta-blocking drugs, benzodiazepines, MAO inhibitors
8. Morbidly obese
9. Open cholecystectomy |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the effect of intravenous clonidine versus intravenous dexmedetomidine on pneumoperitoneum-induced hemodynamic response during laparoscopic cholecystectomy |
from the giving of study drug till the end of the study |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Effect of intravenous clonidine on hemodynamic response during laparoscopic cholecystectomy
2) Effect of intravenous dexmedetomidine on hemodynamic response during laparoscopic cholecystectomy
3) Effect of intravenous normal saline on hemodynamic response during laparoscopic cholecystectomy
4) To compare the effect of all three |
before induction to 5 min after extubation |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
15/09/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Background: Laparoscopic cholecystectomy is the treatment of choice for symptomatic benign gall bladder diseases and has essentially replaced the open technique because of its better postoperative recovery profile. But it is also associated with significant cardiopulmonary changes due to the pressure effect of pneumoperitoneum and the release of catecholamine. Various drugs have been used to prevent these responses like magnesium sulfate, nitroglycerine, clonidine, and dexmedetomidine. Clonidine, a selective alpha-2 adrenergic agonist, and dexmedetomidine, a new generation highly selective alpha-2 adrenoreceptor agonist, inhibit catecholamine release effectively and will be used in this study for achieving haemodynamic stability. Objectives: To compare the effect of intravenous clonidine versus intravenous dexmedetomidine on pneumoperitoneum-induced hemodynamic response during laparoscopic cholecystectomy. Material And Methods: in three groups of 30 each randomly selected patients, one group will receive 50 ml of normal saline, the second group will receive 0.75μg/kg clonidine in normal saline, the third group will receive 0.75μg/kg dexmedetomidine in normal saline and total volume of study drug will be adjusted to 50 ml each administrated for 15 minutes before induction of GA. Expected Benefits: in terms of stable hemodynamics, reduction in induction dose of propofol, decreased post-operative pain, and decreased side effects. |